DEVICE: Nuance® (D813CR11090)
Device Identifier (DI) Information
Nuance®
CR1109
In Commercial Distribution
CR1109
DEN-MAT HOLDINGS, LLC
CR1109
In Commercial Distribution
CR1109
DEN-MAT HOLDINGS, LLC
NUANCE B2 UNIVERSAL SYR
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35870 | Dental composite resin |
A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBF | Material, Tooth Shade, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K101215 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: After extrusion, securely place the cap onto the syringe. This will protect Nuance from ambient light, as well as foreign objects. |
Special Storage Condition, Specify: Keep away from direct sunlight, extreme heat or open flame. |
Special Storage Condition, Specify: Nuance FLOW should not be used past the expiration date listed on the syringe. |
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit |
Handling Environment Temperature: between 36 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
eb55c38f-c6b2-4e2c-af13-40e05631ef1c
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-433-6628
info@denmat.com
info@denmat.com